Endobiliairy radiofrequency ablation for malignant biliairy obstruction, RACCOON-pilot

Endobiliairy radiofrequency ablation for malignant biliairy obstruction due to perihilar cholangiocarcinoma: a pilot study (RACCOON-pilot)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27848

Enrollment

Registered

2020-12-27

Start date

2020-12-27

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parihilair cholangiocarcinoma

Interventions

Endobiliary RFA

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years or older. - Capable of providing written and oral informed consent. - Histological or cytological proof of perihilar CCA (adenocarcinoma)* - Biliary obstruction with indication for drainage (symptomatic (itch or cholangitis) or necessary for systemic therapy). - Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).

Exclusion criteria

Exclusion criteria: - Resectable CCA. - Intrahepatic or distal CCA, or gallbladder cancer. - CCA eligible for liver transplantation. - Life-expectancy less than 3 months. - ERCP and PTD technically not feasible. - Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40 10E9/L). - Carcinoma other than adenocarcinoma. - Implantable pacemaker and implantable cardioverter/ defibrillator

Design outcomes

Primary

Measure	Time frame
The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible, safe in patients with unresectable perihilar cholangiocarcinoma.	—

Secondary

Measure	Time frame
Recurrence of biliary obstruction, quality of life	—

Contacts

Public ContactMattheus Wielenga

Amsterdam UMC

m.c.wielenga@amsterdamumc.nl+31610910885

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)